SAFE AND EFFECTIVE,
BUT OFTEN MISUSED
Good news about over-the-counter (OTC) epinephrine inhalers for asthma: Occasional use appears to be safe and effective in patients with mild, intermittent disease--provided they follow the instructions on the label.
news: "About 20% of the asthma patients who are using
these inhalers probably should not be," said Roy D.
Altman, MD, in an interview with RESPIRATORY
REVIEWS. These patients have
mild-to-moderate persistent asthma and need a physician's
supervision, explained Dr. Altman, a Professor of Medicine
at the University of Miami.
Dr. Altman is also a member of the Council on Scientific Affairs at the American Medical Association (AMA), which recently published a report on the safety of OTC epinephrine inhalers. The AMA asked the Council to investigate this issue because of its concern about the potential for misuse or abuse of OTC inhalers by asthma patients.
In those with mild-to-moderate persistent asthma, for example, it is dangerous to self-treat with OTC inhalers rather than seek medical care. The result may be inadequate or delayed therapy, which can lead to complications or deaths that could have been prevented.
To gather data for their report, the Council members performed a MEDLINE search covering the years 1966 to 1998. Using the key words "asthma," "epinephrine," "adrenergic beta-agonists," "administration," "inhalation," and "drugs, nonprescription," they identified 16 articles.
They found 12 more articles
when they searched the F-D-C Reports file in the
Lexis-Nexis database with the keywords "epinephrine,"
"over-the-counter," and "inhaler." The
Council members also obtained the most recent Food and Drug
Administration (FDA) monograph addressing the safety of
OTC epinephrine inhalers.
"The situation does not seem as bad as we thought it might be," Dr. Altman said. "Not many people have gotten into trouble with these inhalers."
In its monograph, for example, the FDA concluded it was not necessary to limit inhaled epinephrine to prescription use. A 1996 amendment to the monograph requires an approved application for the sale of new OTC bronchodilators, but this amendment was not applied retroactively to existing products and was not prompted by any specific concerns about their safety or efficacy.
When the Council reviewed spontaneous adverse reaction reports for the years 1975 to 1997, it found only 286 adverse reactions and 13 deaths linked to OTC epinephrine inhaler use. Moreover, three of the deaths were believed to be the result of a concomitant medical condition. For the remaining 10 fatalities, a relationship between inhaled epinephrine use and death could not be established.
Because it is unknown whether the availability of OTC epinephrine inhalers causes asthma patients to self-treat rather than see a physician, the Council reviewed data on more than 300,000 households that had reported using a popular brand of OTC epinephrine inhalers. The data came from a nationwide survey commissioned by the inhaler's manufacturer.
DATA SUGGEST MISUSE
Most respondents reportedly had mild asthma and followed the instructions on the label. However, about 20% fulfilled at least one criterion for mild-to-moderate persistent asthma (such as nocturnal symptoms at least once a week) warranting close physician supervision and inhaled corticosteroid treatment. This finding is consistent with a previous small study, which suggested that OTC epinephrine inhalers are not used exclusively by patients with mild, intermittent asthma.
Though fairly abundant, the data in the Council's report were limited, Dr. Altman acknowledged. Most of the information came from small, industry-produced studies, he explained. Nevertheless, the Council made three recommendations as a result of its findings. Those findings are summarized in the box below.
Dr. Altman commented, however, that these recommendations may not, on their own, be enough. For example, strengthening the product label could be helpful in educating patients, but "the only really effective way to educate the public is through the lay press," he concluded.
--Timothy M. Begany
1. Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety
of over-the-counter inhalers for asthma. Report of the Council
on Scientific Affairs. Chest. 2000;118:522-526.
2. Benatar SR. Fatal asthma. N Engl J Med. 1986;314:423-429.
3. US Food and Drug Administration. Cold, cough, allergy,
bronchodilator, and antiasthmatic drug products for over-the-counter
human use: final monograph for OTC bronchodilator products.
Federal Register. 1986;51:35326-35340.
4. Redman CM, Druce HM. Nonprescription bronchodilator use
in asthma. Chest. 1998;114:657-658.
5. Kuschner WG, Hankinson TC, Wong HH, Blanc PD. Nonprescription
bronchodilator medication use in asthma. Chest. 1997;112:987-993.
labels on over-the-counter (OTC) epinephrine inhalers
should be revised to better educate users about
appropriate and inappropriate use, potential dangers,
and the need to seek medical care if asthma symptoms
do not improve. In addition, they should inform
patients about the criteria for the presence of
persistent disease, and they should encourage patients
to discuss with their physicians the use of these
products. (Discussions about label revisions are
already under way at the Food and Drug Administration
FDA should reexamine the possibility of taking the
inhalers off the market.
the products are left on the market, further studies
should be done to determine whether OTC availability
is a risk factor for asthma morbidity and mortality.
by the American Medical Association's Council on Scientific
Data extracted from Dickinson et al. 2000.